CN112773858A - Traditional Chinese medicine composition for treating insomnia, traditional Chinese medicine preparation and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating insomnia, traditional Chinese medicine preparation and preparation method thereof Download PDFInfo
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- CN112773858A CN112773858A CN202110209731.7A CN202110209731A CN112773858A CN 112773858 A CN112773858 A CN 112773858A CN 202110209731 A CN202110209731 A CN 202110209731A CN 112773858 A CN112773858 A CN 112773858A
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- A61P25/20—Hypnotics; Sedatives
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Abstract
The invention discloses a traditional Chinese medicine composition for treating insomnia, a traditional Chinese medicine preparation and a preparation method thereof, wherein the traditional Chinese medicine composition comprises the following components in parts by weight: 15-21 parts of cape jasmine, 10-14 parts of fermented soybean, 5-7 parts of Chinese yam, 5-7 parts of poria cocos, 1-3 parts of ginseng, 1-3 parts of saffron crocus and 1-3 parts of saussurea involucrate. The preparation form is an effervescent preparation, and the preparation method comprises the following steps: pulverizing the medicines except for the snow lotus to obtain powder I; crushing the snow lotus to obtain snow lotus powder; adding water into the powder I, reflux-extracting for 3 times, and mixing extractive solutions; ultrasonically extracting herba Centellae powder with ethanol for 3 times, mixing extractive solutions, and recovering solvent; mixing the first extractive solution and herba Saussureae Involueratae extractive solution, concentrating into dry extract, and pulverizing to obtain extract powder; and preparing the extract powder into an effervescent agent. The traditional Chinese medicine preparation can effectively solve the problems of poor treatment effect, dependence after long-term administration and inconvenience in administration of the existing medicines.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating insomnia, a traditional Chinese medicine preparation and a preparation method thereof.
Background
The traditional Chinese medicine considers that the normal sleep of a person is dominated by the heart spirit, and the sleep state is determined when yang qi turns from moving to static, otherwise, the waking state is determined when the yang qi turns from static; therefore, the normal sleeping mechanism of a person is the result of natural and regular transformation of yin and yang. Once this rule is broken, insomnia can occur. Long-term insomnia not only affects the quality of life of patients and damages cognitive functions, but also brings substantial damage to organisms, such as hypertension, diabetes, heart disease and the like. The treatment method of insomnia mainly comprises cognitive therapy and drug therapy, but mainly comprises drug therapy. However, western medicine treatment is usually poor in curative effect on chronic insomnia patients due to large adverse reactions, so that the problem of searching for a medicine with exact curative effect and small adverse reactions is still a major problem in insomnia treatment. With the continuous development of traditional Chinese medicine research, the traditional Chinese medicine gradually receives more and more attention in the treatment of insomnia due to the characteristics of good curative effect and small adverse reaction, and has great development prospect. At present, most of the traditional Chinese medicines are applied to clinic in a compound form
The traditional common extraction methods of the traditional Chinese medicine preparation comprise a decoction method, an immersion method, a reflux method, a percolation method, a steam distillation method and the like, but have a plurality of problems, such as retention of effective components, large loss of the effective components when ineffective components are removed, more processes, long period, high cost, judgment of the quality of the preparation by index components, and neglect of the overall action and pharmacodynamic reaction of the prescription.
For the dosage form, the clinically used Chinese patent medicine for treating insomnia is mostly pills, powder, capsules, oral liquid and the like, and the Chinese patent medicines mainly comprising tablets, especially effervescent tablets are fewer. The existing dosage forms are not very suitable for the elderly, children and patients with dysphagia.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides the traditional Chinese medicine composition for treating insomnia and the preparation method thereof, and the traditional Chinese medicine preparation can effectively solve the problems of poor treatment effect, dependence after long-term administration and inconvenience in administration of the existing medicines for treating insomnia.
In order to achieve the purpose, the technical scheme adopted by the invention for solving the technical problems is as follows:
a traditional Chinese medicine composition for treating insomnia comprises the following components in parts by weight: 15-21 parts of cape jasmine, 10-14 parts of fermented soybean, 5-7 parts of Chinese yam, 5-7 parts of poria cocos, 1-3 parts of ginseng, 1-3 parts of saffron crocus and 1-3 parts of saussurea involucrate.
Further, the paint comprises the following components in parts by weight: 18 parts of cape jasmine, 12 parts of fermented soybean, 6 parts of Chinese yam, 6 parts of poria cocos, 1 part of ginseng, 1 part of saffron and 1 part of saussurea involucrate.
In the scheme, the gardenia is bitter in nature and cold in taste, enters heart, lung and triple energizer channels, and has the effects of purging fire, relieving restlessness, clearing heat, promoting urination, cooling blood and removing toxicity. Can be used for treating pyretic vexation, jaundice, dark urine, stranguria with blood, hematemesis, epistaxis, conjunctival congestion, swelling and pain, and pyocutaneous disease due to pathogenic fire; it can be used for treating sprain, contusion and pain.
The fermented soybean is bitter in property, pungent and cool in flavor, enters lung and stomach meridians, and has the effects of relieving exterior syndrome, relieving restlessness and dispersing stagnated heat. Can be used for treating common cold, headache due to cold and heat, vexation, chest distress, and insomnia due to asthenia.
The Chinese yam is sweet, warm, mild and nontoxic, has the effects of tonifying spleen, removing dampness, tonifying qi, benefiting lung, reinforcing kidney and replenishing vital essence, and has the effect of treating and tonifying cough due to lung deficiency, diarrhea due to spleen deficiency, spermatorrhea due to kidney deficiency, leukorrhagia, frequent urination and the like.
Poria has sweet, light and neutral taste, and has effects of promoting diuresis, eliminating dampness, invigorating spleen and calming heart. Can be used for treating edema, oliguria, phlegm and fluid retention, dizziness, palpitation, spleen deficiency, anorexia, loose stool, diarrhea, uneasiness, palpitation, and insomnia.
Ginseng is sweet in nature, slightly bitter and neutral in taste, and has the effects of invigorating primordial qi, restoring pulse, relieving depletion, invigorating spleen, benefiting lung, promoting fluid production, and tranquilizing. Can be used for treating asthenia, collapse, cold limbs, weak pulse, spleen deficiency, anorexia, lung deficiency, cough, asthma, body fluid deficiency, thirst, internal heat, asthenia, palpitation, insomnia, sexual impotence, and cold womb; treatment of heart failure, cardiogenic shock.
The saffron has sweet taste and neutral nature, and has effects of invigorating heart and liver channel, promoting blood circulation for removing blood stasis, cooling blood, removing toxic substance, resolving stagnation, and tranquilizing mind, and can be used for treating puerperal blood stasis, toxic heat macula, melancholy, stuffiness, palpitation, and mania.
Saussurea involucrate is warm in nature and sweet and bitter in taste, enters liver, spleen and kidney meridians, has the effects of dispelling cold, tonifying yang, regulating menstruation and stopping bleeding, and is used for treating impotence, waist and knee weakness, female irregular menstruation, metrorrhagia and metrostaxis and leukorrhagia, rheumatic arthritis, traumatic hemorrhage and other diseases.
A Chinese medicinal preparation for treating insomnia comprises the above Chinese medicinal composition.
Furthermore, the dosage form of the traditional Chinese medicine preparation is effervescent tablets.
The preparation method of the traditional Chinese medicine preparation for treating insomnia comprises the following steps:
(1) pulverizing fructus Gardeniae, semen Sojae Preparatum, rhizoma Dioscoreae, Poria, Ginseng radix and stigma croci Sativi to obtain powder I; crushing the snow lotus to obtain snow lotus powder;
(2) adding water into the powder I, reflux-extracting for 3 times, and mixing extractive solutions; the pH values of the 1 st to 3 rd times of water are 1.5 to 2.5, 6.5 to 7.5 and 8.0 to 9.0 respectively, and the using amount of the water is 8 to 14 times of the mass of the powder;
(3) ultrasonically extracting herba Saussureae Involueratae powder with ethanol for 3 times, mixing extractive solutions, and rotary evaporating to recover solvent, wherein the pH values of ethanol used in the ultrasonic extraction of 1-3 times are 1.5-2.5, 6.5-7.5 and 8.0-9.0, and the ethanol dosage is 8-14 times of the weight of herba Saussureae Involueratae powder;
(4) combining the extracting solution in the step (2) and the extracting solution in the step (3), concentrating under reduced pressure to obtain dry extract, and crushing to obtain extract powder;
(5) and (4) uniformly mixing the extract powder obtained in the step (4), an effervescent agent and a flavoring agent, and then sequentially preparing a soft material, granulating, drying, adding a lubricant and tabletting.
Further, the particle size of the powder I in the step (1) is 10-20 meshes, and the particle size of the snow lotus powder is 150-200 meshes.
Further, the optimum pH values of the water at the 1 st to the 3 rd times in the step (2) are 2.5, 7.0 and 9.0, respectively, and the amount of the water is 12 times of the mass of the powder.
Further, the reflux extraction temperature in the step (2) is 40-95 ℃, and the extraction time is 0.5-1.5 h.
Further, the most suitable pH values of the ethanol used in the ultrasonic extraction of the 1 st to 3 rd times in the step (3) are 2.0, 6.5 and 9.0 in sequence, and the using amounts of the ethanol are respectively 10 times of the mass of the snow lotus powder.
Further, the volume concentration of the ethanol in the step (3) is 50-90%.
Further, the ultrasonic extraction temperature in the step (3) is 40-90 ℃, and the extraction time is 30-45 min.
Further, the grain diameter of the extract powder in the step (4) is 80-120 meshes
Further, the specific operation in the step (5) is as follows: and (4) uniformly mixing the extract powder in the step (4), an effervescent agent and a flavoring agent, then adding ethanol into the mixture to prepare a soft material, sieving the soft material with a 16-mesh sieve to prepare wet granules, drying the wet granules at the temperature of 40-60 ℃, finishing granules, then adding a lubricant into the wet granules, uniformly mixing the granules and tabletting to prepare the effervescent tablet.
Further, in the step (5), in the effervescent tablet, an acid agent accounts for 5-20% of the mass of the effervescent tablet, an alkali agent accounts for 5-30% of the mass of the effervescent tablet, the acid agent is at least one of citric acid, tartaric acid, fumaric acid, adipic acid and malic acid, and the alkali agent is sodium carbonate, sodium bicarbonate or potassium bicarbonate.
Further, in the step (5), the lubricant is one or more of magnesium stearate, polyethylene glycol and magnesium lauryl sulfate, and the lubricant accounts for 0.5-5% of the mass of the effervescent tablet.
Further, in the step (5), a flavoring agent is one or more of sucrose, lactose, sodium cyclamate and aspartame, and the flavoring agent accounts for 10-50% of the effervescent tablet by mass.
In the scheme, the solvents with different pH values are used for extracting the traditional Chinese medicine, the transportation and absorption process of the medicine in the gastrointestinal tract is simulated, active mixed ingredients are considered, monomer ingredients are used as indexes, the effective ingredients can be fully separated and extracted, and the loss of the effective ingredients is small.
The beneficial effects produced by the invention are as follows: according to the invention, gardenia is a monarch drug and mainly used for clearing away heart-fire and reducing pathogenic fire; the fermented soybean is used as a ministerial drug and mainly used for clearing heat and relieving restlessness; the Chinese yam and the tuckahoe are adjuvant drugs and mainly used for tonifying spleen and promoting diuresis; the ginseng, the saffron and the snow lotus are used as guiding drugs, the traditional Chinese medicine composition is scientific and reasonable in matching, the medicines interact with each other, the effect of treating insomnia is achieved by clearing away heart-fire and dredging heart and kidney, the curative effect is definite, the medicine is a pure traditional Chinese medicine preparation, the safety is high, no toxic or side effect exists, and the medicine is suitable for long-term administration of patients.
The traditional Chinese medicine preparation is an effervescent agent, releases a large amount of carbon dioxide in an effervescent state after meeting water, so that the medicine composition has quick effect and high bioavailability, and is very suitable for the old and patients with dysphagia.
Detailed Description
Example 1
The traditional Chinese medicine composition for treating insomnia is characterized by comprising the following components in parts by weight: 15 parts of gardenia, 10 parts of fermented soybean, 5 parts of Chinese yam, 5 parts of poria cocos, 1 part of ginseng, 1 part of saffron and 1 part of saussurea involucrate; auxiliary materials: 10% of effervescent agent, 5% of potassium bicarbonate, 0.5% of magnesium stearate and 10% of cane sugar.
A preparation method of an effervescent agent for treating insomnia comprises the following steps:
(1) pulverizing fructus Gardeniae, semen Sojae Preparatum, rhizoma Dioscoreae, Poria, Ginseng radix and stigma croci Sativi, sieving with 10 mesh sieve to obtain powder I; crushing saussurea involucrate and sieving the powder with a 150-mesh sieve to obtain saussurea involucrate powder;
(2) adding water into the powder I, extracting under reflux for 3 times at 95 deg.C for 0.75 hr, filtering with 100 mesh sieve, and mixing extractive solutions; the pH values of the 1 st to 3 rd times of water are 2.0, 6.5 and 8.0 respectively, and the using amounts of the water are 6 times, 8 times and 10 times of the volume of the powder respectively;
(3) ultrasonically extracting herba Saussureae Involueratae powder with 60% ethanol for 3 times at 50 deg.C for 35min, mixing extractive solutions, and rotary evaporating to recover solvent, wherein the pH values of ethanol used in the ultrasonic extraction of 1-3 times are 2.0, 6.5 and 8.0, and the ethanol dosage is 6 times, 8 times and 10 times of the volume of herba Saussureae Involueratae powder;
(4) mixing the extractive solution of step (2) and the extractive solution of step (3), concentrating under reduced pressure at 60 deg.C to obtain dry extract, pulverizing, and sieving with 100 mesh sieve to obtain extract powder;
(5) and (3) uniformly mixing the extract powder obtained in the step (4), an effervescent agent and a flavoring agent, adding ethanol into the mixture to prepare a soft material, sieving the soft material with a 16-mesh sieve to prepare wet granules, drying the wet granules at 40 ℃, grading, adding magnesium stearate which is sieved with a 80-mesh sieve, uniformly mixing, and tabletting to obtain the effervescent tablet.
Example 2
The traditional Chinese medicine composition for treating insomnia is characterized by comprising the following components in parts by weight: 21 parts of cape jasmine, 14 parts of fermented soybean, 7 parts of Chinese yam, 7 parts of poria cocos, 3 parts of ginseng, 3 parts of saffron crocus and 3 parts of saussurea involucrate; auxiliary materials: effervescent agent: 5% of citric acid, 10% of potassium bicarbonate, 0.5% of polyethylene glycol and 10% of lactose.
A preparation method of an effervescent agent for treating insomnia comprises the following steps:
(1) pulverizing fructus Gardeniae, semen Sojae Preparatum, rhizoma Dioscoreae, Poria, Ginseng radix and stigma croci Sativi, and sieving with 20 mesh sieve to obtain powder I; crushing the snow lotus and sieving the crushed snow lotus with a 200-mesh sieve to obtain snow lotus powder;
(2) adding water into the powder I, extracting under reflux for 3 times at 60 deg.C for 1 hr, filtering with four layers of gauze, and mixing extractive solutions; the pH values of the 1 st to 3 rd times of water are 2.5, 6.5 and 8.0 respectively, and the using amounts of the water are 6 times, 8 times and 20 times of the volume of the powder respectively;
(3) ultrasonically extracting herba Saussureae Involueratae powder with 70% ethanol for 3 times at 60 deg.C for 35min, mixing extractive solutions, and rotary evaporating to recover solvent, wherein the pH values of ethanol used in the ultrasonic extraction of 1-3 times are 2.5, 6.5 and 8.0, and the ethanol dosage is 8 times, 10 times and 20 times of the volume of herba Saussureae Involueratae powder;
(4) mixing the extractive solution of step (2) and the extractive solution of step (3), concentrating under reduced pressure at 60 deg.C to obtain dry extract, pulverizing, and sieving with 100 mesh sieve to obtain extract powder;
(5) and (3) uniformly mixing the extract powder obtained in the step (4), an effervescent agent and a flavoring agent, adding ethanol into the mixture to prepare a soft material, sieving the soft material with a 16-mesh sieve to prepare wet granules, drying the wet granules at 40 ℃, grading, adding magnesium stearate which is sieved with a 80-mesh sieve, uniformly mixing, and tabletting to obtain the effervescent tablet.
Example 3
The traditional Chinese medicine composition for treating insomnia is characterized by comprising the following components in parts by weight: 18 parts of gardenia, 12 parts of fermented soybean, 6 parts of Chinese yam, 6 parts of poria cocos, 1 part of ginseng, 1 part of saffron and 1 part of saussurea involucrate; auxiliary materials: effervescent agent: 10% of citric acid, 10% of sodium bicarbonate, 1% of magnesium lauryl sulfate and 15% of sodium cyclamate.
A preparation method of an effervescent agent for treating insomnia comprises the following steps:
(1) pulverizing fructus Gardeniae, semen Sojae Preparatum, rhizoma Dioscoreae, Poria, Ginseng radix and stigma croci Sativi, and sieving with 20 mesh sieve to obtain powder I; crushing the snow lotus and sieving the crushed snow lotus with a 200-mesh sieve to obtain snow lotus powder;
(2) adding water into the powder I, extracting under reflux for 3 times at 70 deg.C for 1.25 hr, filtering with four layers of gauze, and mixing extractive solutions; the pH values of the 1 st to 3 rd times of water are 1.5, 7.0 and 8.5 respectively, and the using amounts of the water are 10 times, 6 times and 8 times of the volume of the powder respectively;
(3) ultrasonically extracting herba Saussureae Involueratae powder with 80% ethanol for 3 times at 70 deg.C for 40min, mixing extractive solutions, and rotary evaporating to recover solvent, wherein the pH values of ethanol used in the ultrasonic extraction of 1-3 times are 3.0, 7.0 and 8.5, and the ethanol dosage is 10 times, 6 times and 8 times of the volume of herba Saussureae Involueratae powder;
(4) mixing the extractive solution of step (2) and the extractive solution of step (3), concentrating under reduced pressure at 60 deg.C to obtain dry extract, pulverizing, and sieving with 100 mesh sieve to obtain extract powder;
(5) and (3) uniformly mixing the extract powder obtained in the step (4), an effervescent agent and a flavoring agent, adding ethanol into the mixture to prepare a soft material, sieving the soft material with a 16-mesh sieve to prepare wet granules, drying the wet granules at 40 ℃, grading, adding magnesium stearate which is sieved with a 80-mesh sieve, uniformly mixing, and tabletting to obtain the effervescent tablet.
Example 4
The traditional Chinese medicine composition for treating insomnia is characterized by comprising the following components in parts by weight: 17 parts of cape jasmine, 10 parts of fermented soybean, 7 parts of Chinese yam, 5 parts of poria cocos, 3 parts of ginseng, 3 parts of saffron crocus and 1 part of saussurea involucrate; auxiliary materials: effervescent agent: 15% of citric acid, 20% of sodium bicarbonate, 2% of magnesium stearate and 25% of lactose.
A preparation method of an effervescent agent for treating insomnia comprises the following steps:
(1) pulverizing fructus Gardeniae, semen Sojae Preparatum, rhizoma Dioscoreae, Poria, Ginseng radix and stigma croci Sativi, and sieving with 20 mesh sieve to obtain powder I; crushing the snow lotus and sieving the crushed snow lotus with a 200-mesh sieve to obtain snow lotus powder;
(2) adding water into the powder I, extracting under reflux for 3 times at 80 deg.C for 1.5 hr, filtering with four layers of gauze, sieving with 100 mesh sieve, and mixing extractive solutions; the pH values of the 1 st to 3 rd times of water are 2.5, 6.5 and 8.0 respectively, and the using amounts of the water are 10 times, 12 times and 14 times of the volume of the powder respectively;
(3) ultrasonically extracting herba Saussureae Involueratae powder with 90% ethanol for 3 times at 80 deg.C for 45min, mixing extractive solutions, and rotary evaporating to recover solvent, wherein the pH values of ethanol used in the ultrasonic extraction of 1-3 times are 3.5, 6.5 and 8.0, and the ethanol dosage is 10 times, 12 times and 14 times of the volume of herba Saussureae Involueratae powder;
(4) mixing the extractive solution of step (2) and the extractive solution of step (3), concentrating under reduced pressure at 60 deg.C to obtain dry extract, pulverizing, and sieving with 100 mesh sieve to obtain extract powder;
(5) and (3) uniformly mixing the extract powder obtained in the step (4), an effervescent agent and a flavoring agent, adding ethanol into the mixture to prepare a soft material, sieving the soft material with a 16-mesh sieve to prepare wet granules, drying the wet granules at 40 ℃, grading, adding magnesium stearate which is sieved with a 80-mesh sieve, uniformly mixing, and tabletting to obtain the effervescent tablet.
Example 5
A traditional Chinese medicine composition for treating insomnia comprises the following components in parts by weight: 21 parts of cape jasmine, 10 parts of fermented soybean, 7 parts of Chinese yam, 5 parts of poria cocos, 1 part of ginseng, 2 parts of saffron crocus and 2 parts of saussurea involucrate; auxiliary materials: effervescent agent: 20% of citric acid, 30% of sodium bicarbonate, 3% of polyethylene glycol and 30% of aspartame.
A preparation method of an effervescent agent for treating insomnia comprises the following steps:
(1) pulverizing fructus Gardeniae, semen Sojae Preparatum, rhizoma Dioscoreae, Poria, Ginseng radix and stigma croci Sativi, and sieving with 20 mesh sieve to obtain powder I; crushing the snow lotus and sieving the crushed snow lotus with a 200-mesh sieve to obtain snow lotus powder;
(2) adding water into the powder I, extracting under reflux for 3 times at 90 deg.C for 1 hr, filtering with four layers of gauze, and mixing extractive solutions; the pH values of the 1 st to 3 rd times of water are 2.0, 7.0 and 9.0 respectively, and the using amounts of the water are 12 times, 8 times and 10 times of the volume of the powder respectively;
(3) ultrasonically extracting herba Saussureae Involueratae powder with 90% ethanol for 3 times at 90 deg.C for 30min, mixing extractive solutions, and rotary evaporating to recover solvent, wherein the pH values of ethanol used in the ultrasonic extraction of 1-3 times are 4, 7 and 9.0, and the ethanol dosage is 12 times, 8 times and 10 times of the volume of herba Saussureae Involueratae powder;
(4) mixing the extractive solution of step (2) and the extractive solution of step (3), concentrating under reduced pressure at 60 deg.C to obtain dry extract, pulverizing, and sieving with 100 mesh sieve to obtain extract powder;
(5) and (3) uniformly mixing the extract powder obtained in the step (4), an effervescent agent and a flavoring agent, adding ethanol into the mixture to prepare a soft material, sieving the soft material with a 16-mesh sieve to prepare wet granules, drying the wet granules at 40 ℃, grading, adding magnesium stearate which is sieved with a 80-mesh sieve, uniformly mixing, and tabletting to obtain the effervescent tablet.
Comparative example 1
The traditional Chinese medicine composition for treating insomnia is characterized by comprising the following components in parts by weight: 21 parts of cape jasmine, 5 parts of fermented soybean, 2 parts of Chinese yam, 4 parts of poria cocos, 6 parts of ginseng, 5 parts of saffron crocus and 4 parts of saussurea involucrate; auxiliary materials: effervescent agent: 10% of citric acid, 10% of sodium bicarbonate, 1% of magnesium lauryl sulfate and 15% of sodium cyclamate.
An effervescent preparation for treating insomnia is prepared in the same manner as in example 3.
Comparative example 2
A Chinese medicinal composition for treating insomnia has the same formula as in example 3.
A preparation method of an effervescent agent for treating insomnia comprises the following steps:
(1) pulverizing fructus Gardeniae, semen Sojae Preparatum, rhizoma Dioscoreae, Poria, Ginseng radix and stigma croci Sativi, and sieving with 20 mesh sieve to obtain powder I; crushing the snow lotus and sieving the crushed snow lotus with a 200-mesh sieve to obtain snow lotus powder;
(2) adding water into the powder I, extracting under reflux for 3 times at 70 deg.C for 1.25 hr, filtering with four layers of gauze, and mixing extractive solutions; the amount of water is 10 times, 6 times and 8 times of the volume of the powder respectively;
(3) extracting herba Saussureae Involueratae powder with 50% ethanol for 3 times at 70 deg.C for 40min, mixing extractive solutions, and rotary evaporating to recover solvent, wherein the ethanol content is 10 times, 6 times and 8 times of the volume of herba Saussureae Involueratae powder;
(4) mixing the extractive solution of step (2) and the extractive solution of step (3), concentrating under reduced pressure at 60 deg.C to obtain dry extract, pulverizing, and sieving with 100 mesh sieve to obtain extract powder;
(5) and (3) uniformly mixing the extract powder obtained in the step (4), an effervescent agent and a flavoring agent, adding ethanol into the mixture to prepare a soft material, sieving the soft material with a 16-mesh sieve to prepare wet granules, drying the wet granules at 40 ℃, grading, adding magnesium stearate which is sieved with a 80-mesh sieve, uniformly mixing, and tabletting to obtain the effervescent tablet.
Test examples
1. Subject: wistar rats 90 in half female and half male, with a body mass of 180-220 g, purchased from Daoshu Biotech.
2. Experimental Material
Examples 1-5 effervescent tablets, comparative examples 1-2 effervescent tablets, sodium pentobarbital (Shanghai chemical reagent company, Chinese medicine (group)), sodium chloride injection, p-chlorophenylalanine (PCPA), and water were purified water.
3. Establishment of insomnia model
Rats were acclimatized for 7 days, weighed, and randomly assigned to normal control group (10 animals), building block group (80 animals)
The PCPA is injected into the abdominal cavity of a model-building rat with the dose of 300mg/kg for 1 time every day for 2 days continuously, and the alkalescent normal saline with the same volume is injected into the abdominal cavity of a normal control group for 2 days continuously. After the first intraperitoneal injection of the modeling drug for 36 hours, the normal control group and the modeling group are intraperitoneally injected with pentobarbital sodium 30mg/kg, and the sleep time of the rats is recorded. The result shows that the sleep time of the blank group and the modeling group is improved, and the success of modeling is prompted.
Then, the rats in the model building group were randomly divided into 8 groups, 10 rats in each group were respectively a positive drug group and an effervescent group (7 effervescent tablets in examples 1 to 5 and comparative examples 1 to 2), the normal control group was continuously perfused with normal saline for 7 days 1 time per day, the effervescent tablets in examples 1 to 5 and comparative examples 1 to 2 were perfused for 7 days after intraperitoneal injection of PCPA to the effervescent group, and the positive drug group was perfused with pentobarbital sodium for 7 days after intraperitoneal injection of PCPA to the positive drug group. The sleep time of the rats was then recorded and the results are shown in table 1.
TABLE 1 Effect on sleep latency and sleep time in rats
The data in the table show that the sleep time of rats in the positive drug group is longest, and the sleep time of rats in the effervescent tablet group is greater than that of a normal control group, so that the effervescent tablet has a certain treatment effect on insomnia.
Then measuring the neurotransmitter content in the brain tissue of the rat by the following specific measuring method: the rats were placed in a cotton ball containing soaked ether (ether amount about 1-1.5mL) in a specimen jar and observed until they entered the anesthesia phase. Anesthetizing the rats, perfusing with normal saline via heart, flushing blood, separating hippocampal tissue of each group of rats on ice, weighing, adding normal saline to homogenate the tissue, centrifuging (5000r min-1, 15min), sucking supernatant, and storing in a refrigerator at-80 deg.C. And finally, measuring the content of 5-HT, DA, NE and GABA in rat hippocampal tissues by adopting a double-antibody sandwich enzyme-linked immunosorbent assay.
The results show that compared with a control group, the content of 5-HT and GABA in rats in a model group is obviously reduced, the content of DA and NE in rats in a model group is obviously increased, and compared with the model group, the content of 5-HT and GABA in rats in a low, medium and high dose groups and the content of positive medicament pentobarbital sodium in rats in the model group is obviously increased, and the content of DA and NE in rats is obviously reduced.
Claims (10)
1. The traditional Chinese medicine composition for treating insomnia is characterized by comprising the following components in parts by weight: 15-21 parts of cape jasmine, 10-14 parts of fermented soybean, 5-7 parts of Chinese yam, 5-7 parts of poria cocos, 1-3 parts of ginseng, 1-3 parts of saffron crocus and 1-3 parts of saussurea involucrate.
2. The traditional Chinese medicine composition for treating insomnia according to claim 1, which comprises the following components in parts by weight: 18 parts of cape jasmine, 12 parts of fermented soybean, 6 parts of Chinese yam, 6 parts of poria cocos, 1 part of ginseng, 1 part of saffron and 1 part of saussurea involucrate.
3. A Chinese medicinal preparation for treating insomnia, which comprises the Chinese medicinal composition in claims 1-2.
4. The traditional Chinese medicine preparation for treating insomnia according to claim 3, wherein the dosage form of the traditional Chinese medicine preparation is effervescent tablets.
5. The method for preparing a Chinese medicinal preparation for treating insomnia according to claim 4, comprising the steps of:
(1) pulverizing fructus Gardeniae, semen Sojae Preparatum, rhizoma Dioscoreae, Poria, Ginseng radix and stigma croci Sativi to obtain powder I; crushing the snow lotus to obtain snow lotus powder;
(2) adding water into the powder I, reflux-extracting for 3 times, and mixing extractive solutions; the pH values of the 1 st to 3 rd times of water are 1.5 to 2.5, 6.5 to 7.5 and 8.0 to 9.0 respectively, and the using amount of the water is 8 to 14 times of the mass of the powder;
(3) ultrasonically extracting herba Saussureae Involueratae powder with ethanol for 3 times, mixing extractive solutions, and rotary evaporating to recover solvent, wherein the pH values of ethanol used in the ultrasonic extraction of 1-3 times are 1.5-2.5, 6.5-7.5 and 8.0-9.0, and the ethanol dosage is 8-14 times of the weight of herba Saussureae Involueratae powder;
(4) combining the extracting solution in the step (2) and the extracting solution in the step (3), concentrating under reduced pressure to obtain dry extract, and crushing to obtain extract powder;
(5) and (4) uniformly mixing the extract powder obtained in the step (4), an effervescent agent and a flavoring agent, and then sequentially preparing a soft material, granulating, drying, adding a lubricant and tabletting to obtain the effervescent tablet.
6. The method for preparing a Chinese medicinal preparation for treating insomnia as claimed in claim 5, wherein the particle size of the powder I in step (1) is 10-20 mesh, and the particle size of the herba Centellae powder is 150-200 mesh.
7. The method for preparing a Chinese medicinal preparation for treating insomnia according to claim 4, wherein the temperature of reflux extraction in step (2) is 40-95 ℃ and the extraction time is 0.5-1.5 h.
8. The method for preparing a Chinese medicinal preparation for treating insomnia according to claim 4, wherein the volume concentration of ethanol in step (3) is 50-90%.
9. The method for preparing a Chinese medicinal preparation for treating insomnia according to claim 4, wherein the ultrasonic extraction temperature in step (3) is 40-90 ℃ and the extraction time is 30-45 min.
10. The method for preparing a Chinese medicinal preparation for treating insomnia according to claim 4, wherein the particle size of the extract powder in step (4) is 80-120 meshes.
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Application publication date: 20210511 |